Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-004299-20
    Sponsor's Protocol Code Number:ELND005-AG201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-004299-20
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease.
    Estudio fase 2 prospectivo, aleatorizado, doble ciego, controlado con placebo, de eficacia y seguridad de ELND005 oral para el tratamiento de la agitación y la agresividad en pacientes con enfermedad de Alzheimer moderada o grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
    Un estudio de la eficacia y seguridad de ELND005 para el tratamiento de la agitación y la agresividad en pacientes con enfermedad de Alzheimer de moderada a grave
    A.4.1Sponsor's protocol code numberELND005-AG201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01735630
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorElan Pharma International Ltd
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportElan Pharma International Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointGlobal Project Management
    B.5.3 Address:
    B.5.3.1Street Address7551 Metro Center Drive
    B.5.3.2Town/ cityAustin
    B.5.3.3Post codeTX 7874
    B.5.3.4CountryUnited States
    B.5.4Telephone number001512550 4115
    B.5.5Fax number001512685 9406
    B.5.6E-mailELND005-AG201SM@ppdi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameScyllo-inositol
    D.3.2Product code ELND005
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsciloinositol
    D.3.9.1CAS number 488-59-5
    D.3.9.2Current sponsor codeELND005
    D.3.9.3Other descriptive nameEscilitol, Cocositol, Quercinitol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Agitation and Aggression in Moderate to Severe Alzheimer's Disease
    Agitación y agresividad en pacientes con Enfermedad de Alzheimer de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Agitation and Aggression in Patients With Alzheimer's Disease
    Agitación y agresividad en pacientes con Enfermedad de Alzheimer
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ELND005 treatment compared with placebo in reducing the severity of agitation and aggression at 12 weeks;
    To evaluate the safety and tolerability of the ELND005 dosing regimen in Moderate to Severe AD patients
    Evaluar la eficacia del tratamiento con ELND005, comparado con un placebo para reducir la intensidad de la agitación y la agresividad a las 12 semanas.
    Evaluar la seguridad y la tolerabilidad de la pauta de administración de ELND005 en pacientes con EA moderada o grave.
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.

    To evaluate the efficacy of ELND005 on the patient's dependence status and on caregiver distress.

    To evaluate the effects of the ELND005 dosing regimen on the incidence of brain amyloid-related imaging abnormalities
    Evaluar las variables de evaluación adicionales de eficacia, farmacocinética (FC) y farmacodinamia (FD).

    Evaluar la eficacia de ELND005 sobre el estado de dependencia del paciente y el agotamiento del cuidador.

    Evaluar los efectos de la pauta de administración de ELND005 en la incidencia de anomalías de imágen relacionadas con el amiloide cerebral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Has a diagnosis of Probable AD according to the updated National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; 'McKhann II') Criteria.

    -Has an MMSE score of 10 to 21 (inclusive) at the Screening Visit.

    -Has clinically significant agitation/aggression defined as NPI agitation/aggression subscore of >= 4, with a severity score of >= 2 at both the Screening and Baseline Visits.

    -Has had either no response or suboptimal response to standard nonpharmacological interventions.
    -Diagnóstico de EA probable según los criterios actualizados del National Institute of Neurological and Communicative Disorders y de la Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) ('McKhann II')

    -Puntuación del MMSE de 10 a 21 (ambas inclusive) en la visita de selección.

    -Agitación/agresividad de importancia clínica, definida como una subpuntuación de agitación/agresividad >= 4 en el Neuropsychiatric Inventory (NPI), con una puntuación de intensidad >= 2 en las visitas tanto de selección como basal.

    -Respuesta nula o subóptima a las intervenciones no farmacológicas habituales
    E.4Principal exclusion criteria
    -The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.

    -Has a current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition Text Revision (DSM IV TR).

    -Has symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization.

    -Treated with oral antipsychotic medications within 2 weeks prior to the Screening Visit.

    -Treated with depot preparations of an antipsychotic within 3 months of the Screening Visit.

    -Has Screening Visit brain MRI scan abnormalities that can be attributed to diseases or processes other than AD.
    -La agitación/agresividad es atribuible a la medicación concomitante, las condiciones ambientales o un proceso médico o psiquiátrico activo.

    -Diagnóstico actual de trastorno depresivo mayor según los criterios del Manual diagnóstico y estadístico de los trastornos mentales - cuarta edición, texto revisado (DSM-IV-TR).

    -Síntomas de psicosis (ideas delirantes o alucinaciones) que precisen tratamiento con antipsicóticos u hospitalización psiquiátrica.

    -Tratamiento con medicación antipsicótica oral en las 2 semanas previas a la visita de selección.

    -Tratamiento con preparados de liberación prolongada de un antipsicótico en los 3 meses previos a la visita de selección.

    -Anomalías en la RM cerebral de la visita de selección que pueden atribuirse a enfermedades o procesos diferentes de la EA.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in change from Baseline to Week 12 in NPI-C combined agitation and aggression subscores between the ELND005 and placebo treatment groups
    La diferencia en el cambio desde el momento basal hasta la semana 12 de las subpuntuaciones combinadas de agitación y agresividad del NPI-C entre los grupos tratados con ELND005 y placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Change from Baseline in:
    - mADCS-CGIC agitation domain scores
    - NPI-C subitems of agitation, aggression, apathy, depression/dysphoria, anxiety
    -NPI subitems of aberrant motor behavior, nighttime behavior, disinhibition, delusions, and hallucination
    - Total NPI score
    Cambios desde el momento basal en:
    - puntuaciones del dominio de agitación de la mADCS-CGIC
    - Los subapartados de la agitación, agresividad, apatía, depresión/disforia, ansiedad de la NPI-C
    - Los subapartados del NPI de conducta motriz aberrante, conducta nocturna, desinhibición, ideas delirantes y alucinaciones.
    - Puntuación total del NPI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    A study patient will be considered to have completed Study AG201 at the end of 12 weeks of treatment (ie, Week 12 or End of Study [EOS]).

    This definition is based on the timepoint for primary endpoint assessment. A safety follow-up phase of 6 weeks will occur following the Week 12 or End of Study [EOS] visit.
    Se considerará que un paciente del estudio ha completado el estudio AG201 al final de las 12 semanas de tratamiento (es decir, en semana 12 o el final del estudio [FE]).

    Esta definición se basa en el momento de la valoración de la variable de evaluación primaria. Después de la visita de la Semana 12 o de la visita de final del estudio tendrá lugar una fase de seguimiento de seguridad de 6 semanas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-12
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 02:57:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA